Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04725071
Recruitment Status : Enrolling by invitation
First Posted : January 26, 2021
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This pilot study aims to assess the feasibility of providing immunonutrition supplementation to older burn patients (age 65 and older) and its impact on burn wound healing. Supplements containing arginine and omega 3 fatty acids have been shown to have beneficial effects on healing in other types of wounds but data within the burn population remains limited. 20 participants will be randomized into two arms, immunonutrition or conventional supplement and can expect to be on study for 3 months.

Condition or disease Intervention/treatment Phase
Burn Wound Dietary Supplement: Impact Advanced Recovery Dietary Supplement: Boost High Protein Not Applicable

Detailed Description:

Studies performed previously in burn patients have had mixed patient cohorts with small sample sizes and these have failed to show any large improvements in wound healing. However, in older populations the investigators suspect that immunonutrition supplements may have a larger benefit to these patients as they often present with malnutrition and are more likely to struggle with delayed wound healing. In this pilot study, the investigators look to assess the impact of immunonutrition supplements the burn wound healing of adults over the age of 65 years with 5-15% total burn surface area (TBSA) partial thickness and full thickness burn injuries.

The primary outcome objective of the study will be time to complete wound closure. The secondary objectives include need for surgical grafting, length of inpatient stay, and infections including pneumonia, urinary tract infections, wound infections, and blood stream infections.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immunonutrition
Participants will consume a 6oz immunonutrition drink 2 times daily for 7 days and then once a day for remaining hospital stay.
Dietary Supplement: Impact Advanced Recovery
L-arginine and omega-3 rich supplement

Active Comparator: Conventional Supplement
Participants will consume a 6oz conventional supplement drink 3 times daily for 7 days and then once a day for remaining hospital stay.
Dietary Supplement: Boost High Protein
conventional supplement




Primary Outcome Measures :
  1. Time to Complete Wound Closure [ Time Frame: up to 3 months ]

Secondary Outcome Measures :
  1. Incidence of Surgical Grafting [ Time Frame: up to 3 months ]
  2. Length of Inpatient Stay [ Time Frame: up to 3 months ]
  3. Incidence of Infections [ Time Frame: up to 3 months ]
    Infectious complications include pneumonia, urinary tract infection, wound infection, and blood stream infection.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has partial of full thickness thermal injury of 5-15% of total body surface area (TBSA)
  • Subject has an inpatient admission for their burn
  • Subject or authorized decision maker understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator

Exclusion Criteria:

  • Subject with inhalation injury and/or intubation
  • Subject receiving immunosuppressive medications including chronic steroids, immune modulating medications, and chemotherapy prior to admission
  • Subject with pre-existing severe chronic liver disease or end stage renal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725071


Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: Rebecca A Busch, MD, FACS University of Wisconsin, Madison
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04725071    
Other Study ID Numbers: 2020-1692
A539714 ( Other Identifier: UW Madison )
SMPH/SURGERY/TRAUMA ( Other Identifier: UW Madison )
Protocol Version 1/14/2021 ( Other Identifier: UW Madison )
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
immunonutrition
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Burns